Protecting the Blind in Clinical Trial Shipments

Striking a balance between effective study drug inventory control and efficient management of inventories and shipping costs is not always easy – especially when you are faced with the real-life complexities of clinical trials.

The most efficient ways to manage drug supply are:

  1. Automated “Predictive Resupply”: These algorithms are used for studies that have high enrollment, fewer days between visits, titration, and or other complexities.
  2. “Static Resupply”: These algorithms are used when studies have lower enrollment, longer periods of time between visits, and simple dosing assignments.

However, there are varying degrees of effectiveness when it comes to optimizing shipment efficiencies. Shipping costs can be at odds with shipment algorithms, especially when the blind must be protected. This becomes especially critical to small studies or studies with limited amounts of drug.

It is generally agreed that a minimum resupply of two kits is good industry practice for avoiding “partial unblinding” that can occur from allowing one-kit replacement shipments.

The issue:

When the first subject is in for the randomization visit and receives their kit, a shipment request is subsequently generated the same day for just one kit.  The site coordinator sees there are presently two kits in the inventory and suspects the next subject to be assigned the kit on the new shipment request will be on the same treatment arm as the first subject randomized.

The solution:

In the Veeva RTSM system, disallowing one-kit shipments regardless of whether predictive or static algorithms are used is a configuration setting that can be determined by the client. When this setting is chosen, the system will ensure that an additional treatment kit is randomly selected and added to any shipment that would otherwise include only one treatment kit.


If you have questions on how your RTSM can help balance drug inventory and shipping costs while protecting randomization?  Please contact us for more information!